Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781 190. Calibrator designed for th
FDA device recall Z-2001-2009 · posted 2009-09-10 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the application of the force required to open the bottles.
- Action taken
- Roche Diagnostics Corp. notified Consignees via letter dated April 22, 2009 and instructed to not use excessive force when opening bottles and contact the firm for product replacement instead. A Fax Back Form was included for customers to return via fax to 1-888-345-0480. For further information, contact your Roche Diagnostics representative or call 1-800-428-5074.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- DKB
- Quantity affected
- 3,970 bottles of both products
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-04-22
- Date posted
- 2009-09-10
- Date terminated
- 2009-12-07
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRECISET TDM I AND PRECISET TDM II CALIBRATORS (K031856) | Roche Diagnostics Corp. | 2003-08-06 |